Hansoh Pharma's Ameile® (Almonertinib) Granted Fourth Indication in China for Adjuvant Treatment of Resected EGFR-Mutated NSCLC

May 09, 2025 15:35 CST Updated 15:35

Hansoh Pharma

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May 9，NMPA official website shows that Hansoh Pharma"Almonertinib Mesylate Tablets"(Amadea®)Approved for a New Indication(Application No.: CXHS2400060)，Used for epidermal growth factor receptor（EGFR）Exon 19 deletion or Exon 21（L858R）Positive for substitution mutationNon-Small Cell Lung Cancer（NSCLC）Post-Tumor Resection in Adult PatientsAdjuvant Therapy。

Screenshot source:NMPA Official Website

It is worth mentioning that this is the approval and market launch of Ameitinib.The Fourth Indication。

Ameitinib was developed by Hansoh Pharma. This drug innovatively introduces a cyclopropyl structure, which has good liposolubility and stability, can better penetrate the blood-brain barrier, and has a low incidence of adverse reactions. Ameitinib is China's first domestically produced third-generation EGFR-TKI, which was approved for marketing as early as March 2020 and entered the medical insurance directory through negotiation in the same year.

Hansoh Pharma has conducted extensive and in-depth indication layouts for Aumolertinib, which have been successively approved.Second-line Indications、First-line Indications、Maintenance/Consolidation Therapy, and has now been approved againIndications for Adjuvant Therapy。

Beyond the approved indications, Hansoh has also explored Aumetinib.Combination Chemotherapy(Pemetrexed and Platinum)First-line treatment for NSCLC, this indication has also been submitted for marketing in November 2024.（CXHS2400127）Insight database is expected to be approved in the second half of this year.

Previously Approved Indications for Ameitinib

Screenshot source: Insight Database Web Version

This marketing approval is based on the Phase III clinical trial HS-10296-302 study.（NCT04687241）The positive data. This is a randomized, controlled, double-blind, multi-center Phase III clinical study aimed at evaluating the efficacy and safety of Aumolertinib Mesylate versus placebo for adjuvant treatment of Stage II-IIIB NSCLC with positive epidermal growth factor receptor-sensitive mutations.

The primary endpoint was progression-free survival assessed by an independent review committee.（DFS）, secondary endpoints include DFS assessed by investigators, 2-year, 3-year, and 5-year DFS rates, OS, 5-year OS rate, and safety, etc.

Clinical Trial Timeline

Screenshot source: Insight Database Web Version

At the 2025 AACR Annual Meeting, Hansoh Pharma Made Its DebutThe study results were published. The study included a total of 214 Chinese patients who were randomly assigned to receive either Aumolertinib or placebo treatment.The median follow-up time assessed by BICR was 27.6 months.

Results showShow, AumetinibGroupmDFS not reaching BICR assessment, while the placebo group was 19.4 months.(HR 0.166, p<0.0001)。Ametinib GroupThe 2-year DFS rate was 88.2%., and 40.6% in the placebo group. The DFS assessed by the investigators was consistent with the BICR evaluation results. At the time of data cutoff, the OS data were not yet mature.(Omomitini and Placebo OS Maturity: 2.8% vs. 3.8%)。

In terms of safety, the incidence rates of adverse events leading to dose interruption, dose reduction, and discontinuation in the Aumetinib group and the placebo group were 12.3% vs. 17.8%, 9.4%, respectively.vs. 1.9% and 0.9%vs. 0. No new safety risks observed.

The competition for EGFR inhibitors in China is exceptionally fierce, with the Insight database showing that there are already7 Third-Generation EGFR-TKIsApproved for marketing in China, except for Aumolertinib, the others areLiotinib(Aosaikang/Xinda)、Ruietinib(Shenghe Pharma), Rezotinib(Better Pharma)、Befotini(Yi Fang Bio / Betta Pharmaceuticals), Fumetinib(Ailis Pharmaceutical)and Osimertinib(AstraZeneca)。

However, among many similar domestically produced drugs, Aumetinib has the most and fastest indications layout, running in the first tier.

Source of screenshot: Insight Database

Cover Source:Company Logo

Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If you have any needs, please consult and contact正规医疗机构.

Editor：ccai

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